Primary end point occurred in lower percentage of patients in 180-day period; difference not significant
THURSDAY, Feb. 21, 2019 (HealthDay News) — In high-risk ambulatory patients with cancer, the incidence of venous thromboembolism or death due to venous thromboembolism during 180 days is not significantly reduced for rivaroxaban compared with placebo, according to a study published in the Feb. 21 issue of the New England Journal of Medicine.
Alok A. Khorana, M.D., from the Taussig Cancer Institute in Cleveland, and colleagues conducted a randomized trial involving high-risk ambulatory patients with cancer (Khorana score of ≥2) and without deep vein thrombosis at screening who received rivaroxaban or placebo daily for up to 180 days. A total of 841 patients underwent random assignment.
The researchers found that the primary end point (composite of objectively confirmed proximal deep vein thrombosis in a lower limb, pulmonary embolism, symptomatic deep vein thrombosis in an upper limb or distal deep vein thrombosis in a lower limb, and death from venous thromboembolism) occurred in 6 and 8.8 percent of patients in the rivaroxaban and placebo groups, respectively (hazard ratio, 0.66; 95 percent confidence interval, 0.4 to 1.09; P = 0.1) in the period up to day 180. The primary end point occurred in 2.6 and 6.4 percent of patients in the rivaroxaban and placebo groups, respectively, in the prespecified intervention-period analysis (hazard ratio, 0.4; 95 percent confidence interval, 0.2 to 0.8).
“In this placebo-controlled trial, we did not establish the benefit of treatment with rivaroxaban, because the between-group difference in the prespecified primary efficacy end point up to day 180 was not significant,” the authors write.
The study was partially funded by Janssen, the manufacturer of rivaroxaban, and Bayer.
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